Abstract
Background. This phase II study was designed to determine the toxicity and efficacy of a low dose of docetaxel plus a standard dose of cisplatin for patients with metastatic non-small-cell lung cancer (NSCLC).
Methods. Eligibility criteria included metastatic disease (stage IV) of NSCLC and a performance status (PS) of 0-2. Cisplatin 80 mg/m2 was given i.v. on day 1 and docetaxel 60 mg/m2 was given i.v. on day 1. Treatment was repeated every 3 to 4 weeks.
Results. Forty-five patients were enrolled in the study, and the median age was 63 years. Forty-two patients (93%) had a PS of 0-1 and 38 (84%) received two to four courses of chemotherapy. The principal toxicity was neutropenia, and grade 3/4 occurred in 36%/49%. Other hematologic toxicities were mild. Of the 45 patients, subsequent chemotherapy was delayed due to toxicities in only 5 patients (11%), and dose modifications were needed in only 3 patients (7%). There were no treatment-related deaths. Non-hematological toxicities were relatively mild. Allergy (2%), skin rash (11%), edema (9%), and neuropathy (9%) occurred infrequently, and all were grade 1 toxicity. Of the 45 patients, 19 showed partial response, giving a response rate of 42%. The median survival time was 43.3 weeks, and the 1-year survival rate of all patients was 38.7%.
Conclusion. This cisplatin/docetaxel combination chemotherapy is an active and non-toxic regimen in patients with metastatic NSCLC, a result which suggests that the combination may be suitable for randomized controlled trials.
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Received: February 24, 2000 / Accepted: June 2, 2000
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Okamoto, H., Watanabe, K., Segawa, Y. et al. Phase II study of docetaxel and cisplatin in patients with previously untreated metastatic non-small-cell lung cancer. Int J Clin Oncol 5, 316–322 (2000). https://doi.org/10.1007/PL00012056
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DOI: https://doi.org/10.1007/PL00012056